What it means for a patient
- A hyaluronic acid filler injected into lips, wrinkles and folds kept close to 60% of its effect at 6 months, and at 12 months in the subgroup checked.
- Most sites needed 1 or 2 injections to level the skin.
- No serious or permanent side effects were seen in this study.
- Limits: the abstract does not say how the effect was measured, does not list minor side effects, and has no comparison group. The 12-month result comes from a subgroup only.
Why this paper matters
The title describes it as the first clinical study of this biodegradable hyaluronic acid implant. It reported how much of the correction lasted to 6 and 12 months.
Overview
The question was how well a new biodegradable tissue augmentation product made from hyaluronic acid works and how long it lasts. It was evaluated at three clinics under the EN 540 directive for medical implants. One hundred patients were fully assessed after treatment in 285 locations.
Findings
- Product: a tissue augmentation implant made from hyaluronic acid.
- Study run at 3 clinics under the EN 540 directive for medical implants.
- 100 patients fully assessed; 285 treatment locations.
- Treatment was complete when the skin was level, after 1 to 2 injections.
- 6-month follow-up of all patients: close to 60% of the effect remained.
- 12-month follow-up of a randomized group of patients: close to 60% of the effect remained.
- No serious or permanent adverse events.
Terms
- Hyaluronic acid: a sugar molecule found naturally in skin that holds water; used as an injectable filler.
- Biodegradable implant: a material placed in the body that the body breaks down over time.
- Tissue augmentation: adding volume under the skin to fill a line, fold or lip.
- Folds: deeper creases in the skin of the face.
- EN 540: a directive for clinical evaluation of medical implants, which the study followed.
- Adverse event: any unwanted effect after treatment.
- Randomized group: patients chosen by chance, here for the 12-month check.